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临床试验/NCT05651139
NCT05651139已完成不适用

The Effectiveness of Using Vibration Device to Ease Pain During Injections Into the Upper Extremity: a Randomized Controlled Trial

Hatan Mortada1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
The effects of vibration on upper extremity injection-induced pain

研究概览

简要总结

Background: Vibratory stimulation is one of several non-pharmacological techniques used to reduce pain. Local vibration therapy generates vibrations that can penetrate up to 6 centimeters into the tissue and is utilized to manage muscle tone, alleviate localized pain, and induce an increase in blood and lymphatic circulation. This therapy is most commonly used to treat chronic pathologies of the muscles, tendons, and joints. A few studies investigating the effects of local vibration therapy on skeletal muscles and joints have found it to be beneficial in improving joint mobility and decreasing pain. Previous reports have indicated that whole-body vibration can suppress chronic low back pain, knee osteoarthritis, and peripheral neuropathy. The aim of this study is to evaluate the effects of the application of vibration stimulation on upper extremity injection-induced pain and satisfaction.

Objectives: The purpose of this study is to assess the effect of vibration stimulation application on upper extremity injection pain and satisfaction.

Methods: An electrical massage kit that induces vibration will be used on adult patients who are scheduled to receive local anesthesia or corticosteroid injections in their upper extremities. Two validated scales will be used to first assess the pain after the injection and the patient's satisfaction following the use of the vibration device.

详细描述

Study design:

randomized controlled trial

Study duration:

12 months, beginning in November 2022 and ending in May 2023.

Study settings:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •At least 18 years of age
  • •American Society of Anesthesiologists (ASA) physical status class I
  • •Pain free
  • •Adult patients scheduled to receive local anesthesia or corticosteroid injections in their upper extremities

排除标准

  • •Those on analgesic medications
  • •Alcoholics, drug abusers
  • •Pregnant patients
  • •Menstruating women
  • •Patients with reported allergies
  • •Patients with acute infections

研究组 & 干预措施

Receiving vibration stimulation post-injection

Experimental

Using a vibration device post-injection on the affected area.

干预措施: Electrical Vibration Device (Device)

control group

No Intervention

No intervention will be conducted

结局指标

主要结局

The effects of vibration on upper extremity injection-induced pain

时间窗: Pain will be measured immediately after receiving the intervention (with in 2 minutes)

Measuring the pain using the Visual Analog Scale (VAS) for pain, which is a validated tool. the scale measures pain from 0 (no pain) to 10 (pain as bad as it could possibly be)

The effects of vibration on injection satisfaction for upper extremity injections

时间窗: The satisfaction will be measured immediately post-injection and intervention (with in 5 minutes)

The satisfaction will be measured using Satisfaction visual analog scale, which is a validated tool. the scale measures the satisfaction from 0 (not satisfied) to 10 (very satisfied)

次要结局

未报告次要终点

研究者

发起方
Hatan Mortada
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Hatan Mortada

Co-investigator

King Saud Medical City

研究点 (1)

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